A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin
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|ClinicalTrials.gov Identifier: NCT00441519|
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : January 12, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: aspirin Drug: omeprazole||Phase 1|
Primary: To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a once-daily dose of 81 mg enteric coated (EC) aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers.
Secondary: To evaluate the safety and gastrointestinal tolerability, including ulcerogenic potential, and the effect on gastric pH of PA 325.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Investigator-Blinded, Stratified, Randomized, Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin|
|Study Start Date :||February 2007|
|Primary Completion Date :||April 2007|
|Study Completion Date :||April 2007|
- The primary endpoint is the occurrence of gastric and/or duodenal bulb lesions meeting Grade 3 or Grade 4 Lanza (1988) scores for the stomach and duodenal bulb (combined).
- Secondary endpoints include the incidence of gastric and/or duodenal ulcers, total number of gastric and/or duodenal erosions, gastric pH and any other GI tolerability issues.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441519
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27517|
|MDS Pharma Services|
|Montreal, Quebec, Canada, H4R2N6|
|Study Director:||Judy Bryson, Pharm. D.||POZEN|